Trials / Recruiting
RecruitingNCT06845202
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 * evaluate the efficacy, safety, tolerability, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALN-4324 | ALN-4324 will be administered subcutaneously (SC) |
| DRUG | Placebo | Placebo will be administered SC |
Timeline
- Start date
- 2025-03-03
- Primary completion
- 2027-08-31
- Completion
- 2027-08-31
- First posted
- 2025-02-25
- Last updated
- 2026-04-17
Locations
20 sites across 5 countries: United States, Argentina, Canada, Germany, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06845202. Inclusion in this directory is not an endorsement.